from the please-tell-me-again-why-making-drugs-unaffordable-will-save-lives dept

Here on Techdirt we've written much about the way Western pharma companies fight for their "right" to charge unaffordable prices for medicines in emerging and developing economies. In particular, they routinely take governments and local generic suppliers to court in an attempt to shore up highly-profitable monopolies on life-saving drugs. But to be fair, it's not only poorer people who are dying as a result of Big Pharma's desire to maximize profits: Western drug companies are equally happy to charge even higher prices in richer countries -- notably in the US. That's old news. But there is a pharmaceutical saga unfolding that manages to combine all the worst aspects of this kind of behavior, and to throw in a few new ones.

It concerns something really exciting and important: a vaccine that shows great promise against the devastating Zika virus, which can cause microcephaly, blindness, deafness, and calcification of the brain in children whose mothers were infected during their pregnancy. If effective, such a vaccine could be a tremendous boon not just for developing countries, but for Western ones too, since the Zika virus has already begun to spread in the US, and Europe. The vaccine was developed at the Walter Reed Army Institute for Research, and the Department of the Army funded its development. Great news, you might think: the US public paid for it, so it's only right that it should have low-cost access to it. Moreover, as an act of compassion -- and to burnish its international image -- the US could allow other countries to produce it cheaply too. But an article in The Nation reports that the US Army has other ideas:

the Army is planning to grant exclusive rights to this potentially groundbreaking medicine -- along with as much as $173 million in funding from the Department of Health and Human Services -- to the French pharmaceutical corporation Sanofi Pasteur. Sanofi manufactures a number of vaccines, but it's also faced repeated allegations of overcharges and fraud. Should the vaccine prove effective, Sanofi would be free to charge whatever it wants for it in the United States. Ultimately, the vaccine could end up being unaffordable for those most vulnerable to Zika, and for cash-strapped states.

The Knowledge Ecology Institute (KEI), led by Jamie Love, made a reasonable suggestion to ensure that those most at need would have access to the drug at a reasonable price. KEI asked that, if Sanofi does get an exclusive deal, it should be obliged to make the vaccine available at an affordable price. The Army said it lacked the ability to enforce price controls, but it would ask those nice people at Sanofi to commit to affordable pricing on a voluntary basis. According to The Nation, those nice people at Sanofi refused. Speaking of nice people at Sanofi, the article notes the following:

Sanofi's record also includes a number of controversies related to its pricing practices, from a $190 million fine to settle charges that it defrauded Medicare and other government programs, to a $109 million fine to settle charges that it illegally provided product kickbacks to doctors. In 2014, a whistle-blower alleged the company engaged in another kickback scheme and the destruction of legal evidence. KEI maintains a comprehensive list of Sanofi's fraud fines, including the latest: a $19.9 million settlement, reached this April, for overcharging the Department of Veterans’ Affairs.

When there is an entire Web page dedicated to listing Sanofi's problems going back to 2009, you really have to wonder why the US Army is so keen to give the company a monopoly on this promising new treatment. The usual argument for the sky-high prices of drugs is that firms must be rewarded for taking on the financial risk of drug development, otherwise they won't proceed, and the world would be the poorer. Except, of course, in this case that risk was entirely borne by the US public, which paid for the early stage development of the vaccine with their taxes. So Sanofi risked nothing, but now looks likely to reap the benefits by being allowed to price the vaccine out of the reach of the people who most need it. You might think there ought to be a law against this kind of behavior. It turns out that there is:

KEI's Jamie Love pointed out that under the Bayh-Dole Act of 1980, it is already illegal to grant exclusive rights to a federally owned invention unless the license holder agrees to make it available at reasonable pricing. But that provision has rarely, if ever, been enforced.

from the good-for-him dept

We were quite disappointed last month to see that Rep. Darrell Issa -- who has done lots of excellent work to encourage more open access to government information -- was sponsoring a bill that would close off open access to government funded research. This is an important issue that we've been following for years. Government funded research means that taxpayer money funded that research... and yet because of ridiculous policies by gatekeeper journals, the public has almost no access to that information. The whole situation is ridiculous. The journals get free labor: they never pay for articles (and, in some fields, academics actually have to pay the journal to get published), they never pay for the peer review. So they get free content and free editing. Then, as part of getting published, they require the researchers to give the journal their copyrights and usually bar them from using that same research elsewhere. Finally, they then sell these journal subscriptions at insane rates: often tens of thousands of dollars a year for a subscription. Only large university libraries and research institutions will pay those fees. It's a huge scam and it's why a ton of academics are boycotting publishing giant Elsevier, (infamous for its fake journal division).

The issue in these bills is that there has been a movement to require any research that is federally funded (taxpayer funded) to be placed in an open access repository one year after it was published. The National Institute of Health (NIH) who funds billions in research every year, has had this policy going for a few years (though journals have even tried nasty tricks, like requiring academics to pay them to "deposit" their own papers into these open repositories). This kind of rule makes plenty of sense: we're talking about publicly funded research after all. It should be open to the public. Giving the journals a one-year headstart on publishing the papers seems like more than enough for them to make money (again, from the "free" content they get).

Except... the journals hate this because they want their lifetime-plus monopoly on this information (which, I'll emphasize once again that they do not pay for). So they've been pushing various bills that would outlaw such open access requirements. And, somehow, they got Darrell Issa to back the latest version of this bill.

Thankfully, however, Rep. Mike Doyle -- who has a long history of being really good on copyright issues -- has introduced a counter bill to Issa's bill (pdf) called the Federal Research Public Access Act of 2012. It really is the mirror image of the Issa bill.

the Federal Government funds basic and applied research with the expectation that new ideas and discoveries that result from the research, if shared and effectively disseminated, will advance science and improve the lives and welfare of people of the United States and around the world; and the Internet makes it possible for this information to be promptly available to every scientist, physician, educator, and citizen at home, in school, or in a library.

The bill would require that all federal agencies establish policies that encourage open and free access to federally funded research. One hopes that Rep. Issa will rethink his position on his bill, and recognize that Doyle's bill is much more aligned with Issa's stated goal (and long-shown commitment) to more open access to government information.